Muscle Aging Evaluation

Not Applicable

Not yet recruiting

• Conditions: Preventing Age-Related Muscle Loss: the Role of Exercise in Improving Strength, Function, and Well-being

• Registration Number: NCT06845748
• Lead Sponsor: University of Milan

Brief Summary

This study aims to assess the effects of physical activity in counteracting muscle aging. The increasing life expectancy worldwide has led to a rise in age-related muscle decline, which negatively impacts strength, function, and overall quality of life. Sedentary lifestyles further accelerate this process, increasing the risk of frailty, falls, fractures, and disability.

This randomized controlled trial (RCT) will investigate whether a structured exercise program can help reduce muscle deterioration. The study will involve 200 participants, divided into three age groups: i) Young adults (18-35 years); ii) Middle-aged adults (35-65 years); iii) Older adults (\>65 years).

Participants will be assigned to either a physical activity intervention group or a control group. The intervention group will follow a 48-week structured program including, muscle-strengthening sessions (bodyweight exercises at home) and aerobic sessions (moderate-intensity cardio exercise). The control group will not receive any exercise prescription.

The primary objective is to evaluate whether physical activity improves muscle strength, measured through handgrip strength at 12 and 48 weeks.

Secondary objectives include: i) assessing changes in muscle mass, function, and quality of life; ii) measuring improvements in physical performance (aerobic capacity, balance, and mobility tests); iii) evaluating psychological and cognitive well-being.

This 48-week trial will consist of: i) baseline assessments (body composition, strength tests, physical and cognitive evaluations); ii) intervention period (12 weeks of structured training for the experimental group); iii) follow-up assessments (at 12 and 48 weeks).

All participants will undergo periodic evaluations, including anthropometric and body composition measurements (weight, BMI, muscle mass), aerobic and muscle strength tests (handgrip, knee extension, 1-rep max tests), functional mobility assessments (six-minute walking test, chair-stand test), psychological and cognitive evaluations (mood profiles, quality of life surveys, cognitive tests).

Engaging in regular exercise may help participants: i) maintain muscle mass and strength; ii) improve physical function and balance; iii) enhance overall well-being and independence; iv) reduce the risk of age-related disabilities.

Additionally, the study aims to provide valuable insights into the role of exercise in healthy aging, helping healthcare providers develop personalized interventions for older adults.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-19
• Study First Submitted QC: 2025-02-19
• Last Update Submitted: 2025-02-19
• Study First Posted: 2025-02-25
• Last Update Posted: 2025-02-25
• Study Start: 2025-04
• Primary Completion: 2026-10
• Study Completion: 2027-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Adults aged 18 years and older.
• Must be able to engage in physical activity as prescribed in the study protocol.
• No pre-existing musculoskeletal conditions that would prevent safe participation.
• No history of hospitalization in the six weeks prior to enrollment.
• No acute or uncontrolled medical conditions that could interfere with exercise participation.
• Willing to sign an informed consent form before participation.

Exclusion Criteria

• Severe Medical Conditions (cardiovascular diseases, severe respiratory diseases, neurological disorders)
• Cognitive and Psychological Conditions (severe cognitive impairment or dementia, psychiatric disorders)
• Pregnancy
• Use of anabolic or muscle-enhancing substances (use of steroids, testosterone therapy, or other performance-enhancing drugs within the past 6 months)
• Participation in ther Clinical Trials

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in handgrip strength at 12 and 48 weeks	Baseline, Week 12, and Week 48	Handgrip strength will be measured using a hand dynamometer to assess the maximal isometric force of the dominant hand. The mean of three trials will be recorded, with 60-second rest intervals between attempts. An increase in handgrip strength over time will indicate the effectiveness of the physical activity intervention in maintaining or improving muscle function in aging adults.

Secondary Outcome Measures

Name	Time	Method
Change in muscle mass	Baseline, Week 12, and Week 48	Body composition, including lean muscle mass, will be assessed using bioelectrical impedance analysis (BIA) to evaluate changes in muscle preservation and hypertrophy.
Change in Lower Limb Strength (Knee Extension Isometric Force, N) at 12 and 48 weeks	Baseline, Week 12, and Week 48	Maximal isometric knee extension force will be measured using a dynamometer to assess improvements in lower limb muscle strength.
Change in Physical Performance (Six-Minute Walk Test, meters) at 12 and 48 weeks	Baseline, Week 12, and Week 48	Walking endurance will be assessed using the Six-Minute Walk Test (6MWT) following the American Thoracic Society guidelines, measuring the total distance covered in six minutes.
Change in Functional Mobility (Chair Stand Test, repetitions) at 12 and 48 weeks	Baseline, Week 12, and Week 48	The 30-second Chair Stand Test will evaluate lower limb strength and endurance by counting the number of times a participant can rise from a chair within 30 seconds.
Change in Balance and Postural Control (Mini-BESTest Score) at 12 and 48 weeks	Baseline, Week 12, and Week 48	Balance and postural control will be measured using the Mini Balance Evaluation Systems Test (Mini-BESTest), which assesses postural adjustments, sensory orientation, and gait stability.
Change in Quality of Life (SF-12 Health Survey Score) at 12 and 48 weeks	Baseline, Week 12, and Week 48	Quality of life will be assessed using the SF-12 questionnaire, which evaluates both physical and mental health components.
Change in Cognitive Function (Trail Making Test, A & B) at 12 and 48 weeks	Baseline, Week 12, and Week 48	Executive function and processing speed will be evaluated using the Trail Making Test (TMT A \& B), where participants connect numbered and lettered sequences as quickly as possible.
Change in Psychological Well-being (Profile of Mood States - POMS) at 12 and 48 weeks	Baseline, Week 12, and Week 48	Mood states will be assessed using the Profile of Mood States (POMS) questionnaire, measuring anxiety, fatigue, vigor, depression, and confusion.

Trial Locations

Locations (1)

Università degli Studi di Milano; 🇮🇹 Milan, Italy